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Click here for CIBINQO Prescribing Information. Adverse event reporting information can be found at the bottom of the page.
JADE REGIMEN was a responder-enriched, randomised, double-blind, placebo-controlled phase 3 trial to evaluate efficacy and safety of CIBINQO in 1,233 patients with moderate-to-severe AD who received CIBINQO 200 mg monotherapy in an initial 12-week open-label induction period and the responders* (n=798) were randomised to CIBINQO 200 mg, CIBINQO 100 mg, or placebo during a 40-week maintenance period to evaluate loss of response or protocol-defined flare† requiring rescue treatment.1
Continuing Dose
200 mg OL → 200 mg Double-Blinded
Reducing Dose
200 mg OL → 100 mg Double-Blinded
In patients who responded* to 12-week treatment with CIBINQO 200 mg open label
Whether patients were continued on CIBINQO 200 mg or dose was reduced to CIBINQO 100 mg, both treatment arms showed a significantly lower risk of flare† vs placebo (treatment withdrawn) through week 521,2‡
†Protocol-defined flare requiring rescue treatment: A loss of at least 50% of the EASI response achieved at week 12 (in the open-label induction period) plus a new IGA score of 2 or higher.
Data limitations
Criteria to determine response in the induction period (achievement of EASI-75 and IGA 0/1 response with ≥2-point reduction) were different from those to determine loss of response or protocol-defined flare (loss of ≥50% of the initial EASI response at week 12 plus an IGA score of ≥2).
IIProtocol-defined flare requiring rescue treatment: A loss of at least 50% of the EASI response achieved at week 12 (open-label induction period) plus a new IGA score of 2 or higher.
Data limitations
During the rescue period, there was no control arm and all patients received CIBINQO 200 mg + TCS open label (patients knew they received active treatment).
Primary endpoint:
Although this clinical trial included adolescents, please note that CIBINQO is indicated for the treatment of moderate-to-severe atopic dermatitis in adults who are candidates for systemic therapy.
Prescribing information
Please see the CIBINQO Summary of Product Characteristics for more information.
In patients who responded* to 12-week treatment with CIBINQO 200 mg open label
Whether patients were continued on CIBINQO 200 mg or dose was reduced to CIBINQO 100 mg, both treatment arms showed a significantly lower risk of flare† vs placebo (treatment withdrawn) through week 521,2‡
JADE REGIMEN showed that most patients who initially responded to CIBINQO 200 mg OL maintained adequate response with reduced dosing.
†Protocol-defined flare requiring rescue treatment: A loss of at least 50% of the EASI response achieved at week 12 (open-label induction period) plus a new IGA score of 2 or higher.
Data limitations
Criteria to determine response in the induction period (achievement of EASI-75 and IGA 0/1 response with ≥2-point reduction) were different from those to determine loss of response or protocol-defined flare (loss of ≥50% of the initial EASI response at week 12 plus an IGA score of ≥2).
Data limitations
During the rescue period, there was no control arm and all patients received CIBINQO 200 mg + TCS open label (patients knew they received active treatment).
Primary endpoint:
Prescribing information
Please see the CIBINQO Summary of Product Characteristics for more information.
Discover the efficacy of CIBINQO
▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 of the SmPC for how to report adverse reactions.
Legal Category: S1A
Further information is available upon request
Adverse events should be reported. Report an adverse event to your national reporting system (HPRA Pharmacovigilance)
Adverse events should also be reported to Pfizer Medical Information on 1800 633 363
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PP-UNP-IRL-0176. January 2023